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Industrial Dimensions of Food Allergy

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Proper management of food allergy risks requires consideration of most steps in ... Joshi P, Mofidi S, Sicherer SH (2002) J Allergy Clin Immunol 109, 1019-1021. ... – PowerPoint PPT presentation

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Title: Industrial Dimensions of Food Allergy


1
Industrial Dimensions of Food Allergy
  • René Crevel
  • Safety and Environmental
  • Assurance Centre
  • Unilever

2
Industrial dimensions of food allergy
  • Now major food safety and public health issue
  • Linked to general rise in atopic disease
  • Intense regulatory scrutiny - EU, US-FDA

3
Industrial dimensions of food allergy
  • Dimension
  • Size of problem how large? How many people are
    affected?
  • Scope of problem what is its nature? What are
    its main elements?

4
Industrial dimensions of food allergy outline
  • Size and scope of food allergy issue
  • Roles of different stakeholders
  • Challenges for the food industry
  • Allergen risk management in the food industry
  • Existing allergens
  • Assessment of allergenic potential of novel
    proteins and foods

5
Food allergy numbers (1)
  • Prevalence 1-2 of total population, 5-8 of
    children i.e. up to 10 million people in EU
  • Actual numbers affected larger, as families and
    carers are included
  • Frequency of severe reactions increasing Sheikh
    and Alves (2000) BMJ 320, 1441

6
Food allergy numbers (2)
  • US-FDA Class 1 2 recalls running at around 100
    per year
  • Cost can be significant - recalls associated with
    Starlink corn cost several hundred million
    dollars
  • Indirect costs associated with damage to
    reputation etc

7
Number of allergy-related recalls by US-FDA
Number
Adapted from Vierk K, Falci K, Wolyniak C,
Klontz KC (2002) J Allergy Clin Immunol 109,
1022-1026.
8
Causes of FDA recalls
9
Food allergy stakeholders
  • Several different stakeholders
  • food allergic consumers and their carers
  • clinicians specialising in food allergy
  • associations for food allergic patients
  • food manufacturers
  • food safety authorities
  • these different stakeholders have different roles
    and responsibilities

10
Food allergy responsibilities of the food
industry (1)
  • For industry (and regulators) two principal
    issues
  • Protecting existing allergic consumers, who know
    they have an allergy to specific foods and need
    to avoid them
  • Protecting potentially susceptible consumers from
    sensitisation to novel allergens

11
Food allergy responsibilities of the food
industry (2)
  • What knowledge do we need to discharge these
    responsibilities?
  • Well-defined ingredients
  • Defined no-effect levels (thresholds) for each
    allergen
  • Procedures to ensure that specific allergen
    levels in products remain below threshold
  • Good predictive models to assess the
    allergenicity of proteins and foods

12
Food allergy challenges for the food industry
  • Commodity goods handling e.g. maize may contain
    up to 2 soybean
  • Manufacturing processes e.g. line sharing
  • Inadequate clinical knowledge
  • no adverse effect level (threshold) not properly
    defined
  • relationship between sensitivity and severity
    undefined
  • significance of cross-reactivity
  • Explicit and understandable labelling

13
Protecting the allergic consumer Unilevers
approach
  • Unilever will enable individuals, who know that
    they suffer from a food allergy, to avoid
    exposing themselves inadvertently to the
    implicated allergens through the use of Unilever
    products.

14
Management of known allergens
  • Proper management of food allergy risks requires
    consideration of most steps in the life cycle of
    a food product
  • Innovation product design and formulation
  • Supply chain
  • Manufacturing protocols
  • Packaging
  • Promotion/advertising
  • Retail
  • Food professionals
  • Fate of unused/unwanted product

15
Protecting the allergic consumer Unilevers
approach
  • To attain the goals it set itself in
    protecting the allergic consumer, Unilever has
    developed
  • an allergen standard policy document which
    describes what we are aiming for
  • a set of guidelines to ensure consistent
    application of our approach to allergens
    throughout a diverse business

16
Protecting the allergic consumer Unilevers
approach
  • How can we protect the existing allergic
    consumer?
  • Inform
  • Avoid presence of specific allergen(s) in products

17
Protecting the allergic consumer Unilever
Standard
  • Common Allergens-
  • substances which are common causes of allergic
    reactions as evidenced by clinical and
    epidemiological data in the markets where the
    product is sold (Codex list )
  • Rare Allergens-
  • allergens which are not prevalent (common) in the
    markets where the product is sold are rare
    allergens

18
Protecting the allergic consumer information (1)
  • Clear and unambiguous product labelling - phrases
    such as may contain strongly discouraged.
  • Labelling rules also apply to any promotional
    items, free samples, in store samples etc
  • Highlight changed formulation to consumer where
    it contains a new common allergen

19
Allergen label recognition
Joshi P, Mofidi S, Sicherer SH (2002) J Allergy
Clin Immunol 109, 1019-1021.
20
Protecting the allergic consumerinformation (2)
  • Carelines to provide additional information to
    consumers or others who may require it
  • Training to appropriate personnel to provide
    accurate information (e.g. consumer care line
    staff)
  • J Allergy Clin Immunol (2002) most allergen
    labels are not understood by consumers

21
Protecting the allergic consumer Avoiding
presence of specific allergen (1)
  • Product design and formulation
  • is inclusion of specific allergen essential to
    product functionality?
  • If specific allergen is present as e.g. a carrier
    for a flavour, can an alternative carrier be
    used?
  • Is target market for product likely to be
    particularly sensitive to a specific allergen?
    e.g. young children and milk

22
Protecting the allergic consumer Avoiding
presence of specific allergen (2)
  • Supply chain assurance of absence of specific
    allergens (questionnaire about specific
    allergens)
  • Is allergen present in ingredient supplied?
  • Is allergen handled in same facility? If so what
    is probability that it could be present by
    cross-contact
  • Approval of supplier conditional upon
    existence/implementation of HACCP plan
  • Backed up by supplier audit
  • Written consent to be obtained by supplier to
    change formulation of supplied ingredient

23
Protecting the allergic consumerpreventing
contact with allergen
  • Questionnaire for suppliers
  • asks about the presence of specific allergens
  • will be specific to allergens of importance in
    the relevant market (Codex list is a minimum)
  • suppliers will be audited against questionnaire
  • but, not foolproof - suppliers need to understand
    the basics about food allergy as well.

24
Protecting the allergic consumer Avoiding
presence of specific allergen
  • Supply chain assurance of absence of specific
    allergens (questionnaire about specific allergens)

25
Protecting the allergic consumer Avoiding
presence of specific allergen
  • Supply chain assurance of absence of specific
    allergens (questionnaire about specific
    allergens) (continued)

In all the questionnaire covers 11 groups of
major allergenic foods
26
Protecting the allergic consumer Avoiding
presence of specific allergen
  • Manufacturing protocols HACCP
  • Clear labelling of specific allergens within
    facility and where necessary, separation
  • Cleaning protocols
  • Scheduling - products containing a specific
    allergen at end of runs
  • Formulation
  • Factory design to minimise cross-contact
  • Treatment of rework (e.g. like into like)

27
Protecting the allergic consumer Avoiding
presence of specific allergen
  • Training of staff
  • to understand allergen issues
  • to understand the importance of procedures
  • Use of analytical techniques for verification and
    troubleshooting
  • can be applied at any stage of the supply chain,
    although not appropriate for routine quality
    control
  • immunochemical methods for some common allergens
  • Other methods also available for more detailed
    allergen characterisation, if required.

28
Protecting the allergic consumerpreventing
contact with allergen
  • Central resources for Unilever companies
  • General and specific expertise relating to
    allergy and allergens
  • Dissemination of information about allergens
    through intranet website
  • Helping to ensure a coordinated approach to
    allergy issues throughout the company

29
Food allergy addressing the health protection
issues
  • Protecting the susceptible individual against
    sensitisation to a novel allergen
  • Responsibility is in respect of novel
    foods/proteins, not existing ones
  • Need is to assess likelihood that a novel
    food/protein will be an allergen
  • Legal requirement within EU (EC258/97)

30
Protecting the susceptible individualassessing
potential allergenicity
31
Protecting the susceptible individualassessing
potential allergenicity
  • Codex Alimentarius Commission (March 2002)
  • Essentially same elements as FAO-WHO (2001)
  • Sequence analysis
  • Resistance to pepsin hydrolysis
  • Serological analysis
  • Confirmatory tests in man, if necessary (e.g.
    skin prick testing),
  • but evaluation emphasising weight of evidence,
    rather than decision tree

32
Conclusions
  • For industry, consideration of food allergy has
    meant numerous changes to food manufacturing
    practices
  • Protection of food-allergic consumers requires
  • detailed consideration of every step in the
    manufacturing and supply chain, including closer
    links with suppliers
  • a much improved understanding of ingredients
  • Many gaps remain, which require collaboration
    with other stakeholders

33
Current available data indicate that it is not
possible to set a limit to the amount of
allergenic protein there must be in a food to
elicit an allergic reaction (US-FDA)
34
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