Industrial Dimensions of Food Allergy

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Industrial Dimensions of Food Allergy

• René Crevel
• Safety and Environmental
• Assurance Centre
• Unilever

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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

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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?

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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

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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

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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

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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.
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Causes of FDA recalls
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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

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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

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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

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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

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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.

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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

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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

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Protecting the allergic consumer Unilevers
approach

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

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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

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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

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Allergen label recognition
Joshi P, Mofidi S, Sicherer SH (2002) J Allergy
Clin Immunol 109, 1019-1021.
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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

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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

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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

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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.

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Protecting the allergic consumer Avoiding
presence of specific allergen

• Supply chain assurance of absence of specific
  allergens (questionnaire about specific allergens)

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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
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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)

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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.

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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

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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)

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Protecting the susceptible individualassessing
potential allergenicity
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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

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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

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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)
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