Best Practice for Food Allergen Management

Control and Management

Best Practice in Australia and Overseas

Rob Sherlock –

B. Apps M.T Technical director FACTA –

Food Allergen Control Training Analysis

The current issue for Australia Prevalence of allergies in AustraliaAustralia and New Zealand have among the highest prevalence of allergic disorders in the developed world. This report estimates that in 2007: 4.1 million Australians (19.6% of the population) have at least one allergy. Hospital admissions for food anaphylaxis in Australia have doubled over the last decade, and increased five-fold in children aged 0-4 years. Peanut allergy has doubled in prevalence in young children over a five year period.

data published in the October issue of the Journal of Allergy and Clinical Immunology (2007;120:878-84).

In 2007, the financial cost of allergies was $7.8 billion.

Anywhere , anytime , anyone !!

AFGC Guide for Allergen Management

The revised AFGC Allergen Management and Labelling guide incorporates a standardised supplier information form for ingredients, recommendations on good manufacturing practices, labelling recommendations and a scientifically based risk assessment process.

http://www.allergenbureau.net/allergen-guide/afgc-allergen-guide/

Basics of Allergen Control and Management

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allergen management plan

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allergen management team

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allergen management policies

Control

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Control of•

intentional ingredients

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and potential cross contact

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Worth noting important to protect not just “

allergen free”

product but allergen containing product from

“foreign “

allergens

Control Mechanisms Separate containers of allergenic components

Coloured scoops

Control–

Cross contact or unintentional presence from •

cross-contact of an ingredient either before it is received or after receipt;

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accidental mis-formulation;•

cross-contact by an allergen from a different product.•

Poor storage and raw material handling •

during production due to residues in shared equipment,•

From airborne dust•

the improper incorporation of re-work material •

Incomplete or incorrect packaging •

human error

The Mechanisms of Control

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Risk assessment

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Resource allocation

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Process control

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Principles and policies

Risk Assessment •Two levels

–Global view• Entire process from receipt of raw materials to release of finished product

•Flow on effect with impact on suppliers , transportation systems and consumers

•Station or team view •Process•Station•Team views

to implement changes

Team View•

Process, station or team views to implement changes –Ingredient receipt team–Storage and warehouse team (of ingredients) –Batching team –Preparation or process–Production team–Quality assurance team–Research and development team

Risk evaluation•

1) Identify allergen containing material –

ingredients–

processing aids,–

Products–

packaging material

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2 ) Map allergen flow thru process or facility –

Provides information on flow thru facility to determine areas of cross contact and review risk level

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Include seasonal and alternate processes•

Rework•

Corrective actions

Raw materials

Finished product

Batching /weighing area

Weighed ingredients

Packaging materials

Large Vol

Blending

Room

Small VolBlending Room

Storage of herbs, spices, oils and flavours

Raw materials

Finished product

Batching /weighing area

Weighed ingredients

Packaging materials

Large Vol

Blending

Room

Small VolBlending Room

Storage of herbs, spices, oils and flavours

Raw materials

Finished product

Batching /weighing area

Weighed ingredients Work in Progress

Packaging materials

Large Vol

Blending

Room

Small VolBlending Room

Storage of herbs, spices, oils and flavours

Risk Evaluation•

3.) Identify specific areas of potential cross contact. –

Subjective assessment of likelihood of cross contact.

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Info from testing results –

hard to clean areas,

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observed inadequate cleaning process .–

inherently risk laden procedures

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4.) Identify label/packaging problems

Danger Signs

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Raw Material•

Shared Equipment

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Unlabelled Product –

prior to labelling ( time dating )

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Lack of a supported training –

What difference does half a bag make ?

12 Point Plan •

1. Supplier approval

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2. Ingredients•

3. Consumer profile

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4. Sanitation•

5. HACCP plan

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6. Employee awareness and assessment

12 Point Plan •

7. Rework

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8. Reformulation•

9. Product research and development

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10. Labelling•

11. Engineering and Maintenance

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12. Action plan

HACCP CCPs for Allergen Control

•5 Critical control procedures–1. Approved supplier program –2. Raw Material control –3. Sanitation

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Segregation•

Scheduling –4. Training and awareness –5. Labelling

1. Supplier Approval•

Supplier should be audited or assessed–

Use of a documented supplier approval process

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Approved suppliers should have a documented and implemented allergen control plan

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Verification of allergen status for at least one product

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Alternative suppliers

2. Raw Material Control•

Knowledge of what allergens are present and

in use in the ingredients

Review of specifications or ingredient statements, •especially before substituting materials

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Awareness of packaging of raw materialsSome packaging contains wheat-based release agents

2. Raw Material Control •

Incomplete packaging may allow the product to become contaminated

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Allergen clean up protocol-

specific

clean up protocol for allergenic ingredients

Flagging of Allergenic Material

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Consistent across Raw Materials ,Warehousing , WIP .Spec sheets

Pallets . Utensils, Finished product

peanut •egg Nuts

IAFP Icons

http://www.foodprotection.org/aboutIAFP/AllergenIconMain.asp

3. Sanitation•

Effective sanitation –

Team must be trained ,competent and sufficient to the task ( time and resources )

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Systems and tools must be appropriate –

Efficiency should be independently verified

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Minimum ATP/ Micro/ Strip tests

3. Sanitation Cross Contamination and Cleaning.

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Visually clean is a good start

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Level of risk –

ppm

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Unlike micro organisms -no control mechanism to reduce the level

3. Sanitation-

Segregation

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Dedicated storage area

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Dedicated lines should be designated to allergen and non-allergen products

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Dedicated Equipment –

does not mean shared occasionally

3. Sanitation –

Scheduling •

Product scheduling

scheduling production runs Run non allergenic products prior to those containing

allergenic ingredients•

Batch production of allergen products

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Allergen-including product is scheduled at end of production run to minimise equipment exposure

long runs of allergenic products should be undertakenminimise changeovers

major clean down.•

Performance of a complete cleanup before running other products

4. Training and Awareness

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Train all personnel in an understanding of necessary measures and the reasons for them

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Allergen awareness should be part of HACCP Plan–

Employees that understand the consequences of allergen exposure in consumers have a higher level of compliance with food safety programs

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in-house training for allergen awareness at the production level should be included in new staff training and existing staff reviews

5. Labelling

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Provide appropriate warning, to potential purchasers, of the presence or possible presence of a major allergen in a product;

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Ensure compliance with labelling regulations, which requires declaration of all ingredients–

Check all incoming ingredients –

even from

approved suppliers–

If an incidental additive or processing aid is derived from an allergenic ingredient, it must be included on the label

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There must be a traceable document trail for labelled product or material specification sheets

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Unlabelled products (E.g. single product in labelled box) must have a system in place to ensure correct final packaging

5. Labelling

Labelling Equipment

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Bagging and labelling equipment shared at the end of a dedicated line is problematic

Vital Voluntary Incidental Trace Allergen Labelling system

A standardised allergen risk assessment tool for food producers.

allows food producers to assess the impact of allergen cross contact and provide appropriate precautionary allergen labelling on their products.

VITAL Procedure

VITAL Calculator and Example -

soup mix

VITAL Explanatory Notes PDF VITAL Decision Tree PDF VITAL Grid PDF VITAL Allergen Residue Detection Table PDF

VITAL Allergenic Protein Levels PDF VITAL Blank Template word document

Voluntary Incidental Trace Allergen Labelling (VITAL)

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Voluntary Incidental Trace Allergen Labelling (VITAL) has been developed to provide a risk based methodology for food producers to use in assessing the impact of allergen cross contact and provide appropriate allergen labelling.

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VITAL uses a three level grid to assist in determining if the presence of residual protein from allergenic substances (refer to Section 1.2) through unavoidable cross contact, requires a precautionary labelling statement.

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VITAL should be used as part of a HACCP based food safety program when conducting the risk assessment for allergenic hazards.

VITAL Action Levels for labellingIn summary the action levels indicated are:� Action Level 1 – Green Zone -

cross contact allergen labelling not required.

� Action Level 2 –

Yellow Zone - cross contact allergen labelling is required for each

relevant allergen using the standard VITAL statement.� Action Level 3 –

Red Zone – significant levels of the allergen are likely to be present.

Labelling of the allergen as an ingredient in the ingredient list is required.

The VITAL cross contact statement should only be used where cross contact is:

� documented using VITAL, and� unavoidable, and sporadic.Cross contact statements should NEVER be used as a substitute for

good manufacturing practice (GMP) or as a generic disclaimer.

Analysis •

Approach is currently loosely based on microbial

principles –

Utilise the same criteria in terms of representative sampling

–Risk based sample numbers •

Visually clean is insufficient to ensure allergen carry over will not take place

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Microbiologically clean –

not allergenically clean

Targeted Analysis

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In order to obtain value from testing you need to know what you are looking for

–Consider the allergen of concern •

Blanket testing is expensive and in many cases unnecessary

–It is important to target the correct allergen

–It is important to consider the nature of the matrix

Informed testing where kits are not available-

Modeling

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Model cleaning validations around currently used allergens •

Characteristics differ so need to consider the nature of the

allergen •

Use a component of similar consistency

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Use a component of significant proportion in the product •

Use a component for which there is a validated test kit

with a credible pedigree

Sampling Issues–Distribution is not homogenous

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May concentrate in the first part of the run•

OR •

May be impacted by hang ups in the system which result in “random”

dumping of allergen–May be particulate and therefore distributed irregularly –May be due to inadequate cleaning

•Use known microbial hot spots• testing for presence of allergens cannot be regarded as a substitute for the precautions and preventive measures

Sampling No. & Sampling Plans

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Microbiological sampling of foodstuffs has a simple risk category plan•

Products are classified into areas of risk as

determined by product end use by the consumer . •

For food borne allergens, thermal treatment by

the consumer and by the food manufacturer may increase the allergenicity •

allergen risk will not increase over time.

Perspective Operators think of GMP in bulk terms but consumer and analysis are sensitive to minute amounts –

one teaspoon ( 1-2.5 gm -) in a 1000 kg.

International Resources

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UK •

Allergy –

what to consider when labelleing

food •

http://www.food.gov.uk/multimedia/pdfs/publication

/allergyjamjar0109.pdf

International Resources

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Guidance on Allergen Management and•

Consumer Information–

Best Practice Guidance on Managing Food Allergens with Particular Reference to Avoiding Cross-Contamination and Using Appropriate Advisory Labelling(e.g. ‘May Contain’

Labelling)

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http://www.food.gov.uk/multimedia/pdfs/maycontainguide .pdf

International Resources

Guide to Allergen Labeling and Advertising : (CFIA):

http://www.inspection.gc.ca/english/fssa/labeti/allerg/allerge.shtmlo

www.healthcanada.gc.ca/foodallergies

Certification Program for food Allergens: www.certification-allergies.com

Water but not as we know it !! •

Fonterra adds milk protein to water•

‘Whole’, the new bottled water product developed by Fonterra utilises Fonterra Ingredients’

ClearProtein™, a whey protein isolate developed at the Fonterra Research Centre in Palmerston North, New Zealand.

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Due to its milk content, Fonterra have advised the drink is not suitable for anyone with cow's milk allergy.

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ClearProteinTM.