risk assessment and management strategies for food allergens

Australian Food and Grocery Council


RISK ASSESSMENT AND

MANAGEMENT STRATEGIES

FOR FOOD ALLERGENS World of Food Safety 2013

Bangkok, Thailand


• Regulatory Requirements

• Good Manufacturing Practice

• HACCP

• Supplier information

• VITAL risk assessment for labelling

• Labelling for allergens

• Mobile Apps helping consumer choices

OVERVIEW

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• Cereals containing gluten • Crustacea and products • Fish and products • Eggs and products • Milk and products • Peanuts and products • Soybeans and products • Tree nuts and products • Sesame seed and products • Sulphite when 10 mg/kg or more added.

• proposed for consideration … Lupin

FOOD LAWS

Regulatory requirements

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• ingredient means any substance, including a food additive, used in the preparation, manufacture or handling of a food.

• The law does not require precautionary statements such as “May contain” .

• “May contain” is a voluntary statement to assist with ‘informed choices’ when there is

a risk of cross-contamination of allergens that are NOT ingredients.

INGREDIENTS AND OTHER SOURCES

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• Regulatory specified allergenic risks • Hazard identification of allergenic ingredients:

– Storage, handling, processing lines and equipment, rework

• Hazard identification of allergenic cross contact: – Equipment and hang-ups, spills, air and water dispersal, packaging,

clothing,

• Hazard control: – formulation, ingredient specification, supplier information and

certification, internal labelling and tagging, segregation, elimination, cleaning, scheduling, stock movement, staff movement, packaging label design, data management

• Monitoring and verification – Documented plan and record keeping, visual checks, laboratory tests

• Implementation and training – System requirements, Internal review, customer complaint

notification, crisis management and recall

GUIDING STRATEGY

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GMP – training for staff & contractors

• Awareness of allergens in raw materials and severity of reaction for consumers

• Procedures for material handling & storage, equipment design and cleaning, packaging, production requirements

• Personal requirements on site, staff food vending machines, hygiene and clothing

• First aid training to use adrenaline auto-injectors for staff at risk from food allergies

• Supported by Management Policies and Commitment

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GMP – product formulation

• Supplier management – Review product information and assess risk – Imported ingredient and country of origin – Ensure notification of change for PIF – Approved supplier list for ingredients

• Raw Material Handling – Identification and unloading procedures – Site management plan for storage and segregation – Cleaning spills, product and waste disposal

• Recipe design and verification – Ensure allergen use consistent with site policy. – Verify ingredient requires is as supplied. – Ensure allergen identified in data for production

scheduling and product labelling

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GMP – manufacturing process

• Factory design – Equipment designed for ease of cleaning – Dedicated lines and equipment if possible – Airflow and dust controlled to avoid cross-

contact

• Production – Restricted staff movement between areas

allergen and allergen-free areas – Production scheduling to avoid cross-

contact – Use of internal colour codes for materials – Use of re-work material – Packaging material

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GMP – cleaning validation

• Documented cleaning system with validation procedures

• Use dedicated cleaning equipment that is itself cleaned after use

• Avoid air guns and high pressure water hoses which can disburse allergens

• Document procedures to clean hidden or static areas in machinery and equipment

• Dismantle and clean equipment according to production schedule requirements

• Undertake verification of cleaning

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GMP – end product testing

• Analytical testing - quality assurance validation of control capability.

• Quantitative values for VITAL assessment.

• Test methods not available for all allergens

• Processing can affect allergen structure – reducing test specificity

• Testing options: – ELISA kits (use in house) – PCR (polymerase chain reaction) – MS (mass spectrometry)

• Methods must be validated for food matrix and reference standard

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• Acceptable to food companies and their suppliers

• Consistent with regulatory and consumer information requirements

• Comprehensive information about ingredients

• Assists with accurate and truthful labelling and improved consumer confidence in allergen statement

FACT FINDING ABOUT INGREDIENTS

Product Information Form (PIF)

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ALLERGENS – OTHER THAN INGREDIENTS

Allergens present from cross-contact:

Identify likelihood

Quantify presence in final product

Remove / reduce / control presence

Provide appropriate consumer advice

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Voluntary Incidental Trace Allergen Labelling

Objectives:

to provide a risk-based methodology for food producers to use in assessing the impact of allergen cross contact & provide appropriate allergen labelling.

to avoid the indiscriminate use of precautionary labelling and thereby preserve its value as a risk management tool.

VITAL

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VITAL is a risk based precautionary labelling system which uses action levels underpinned by scientific evidence

VITAL is a:

• a process, decision tree, grid & calculator and;

• promotes consistent labelling across industry by prescribing when a precautionary label statement is to be applied / avoided

• one labelling approach ‘May be present’

Developed BY industry FOR industry and is adopted on a voluntary basis

Detailed documentation and guidelines.

VITAL PROGRAM

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NO

NO

Does allergen contact product during processing?

Does allergen contact ingredients during handling, storage or packing?

Particulate form

Readily dispersible form

NO CROSS CONTACT

STATEMENT REQUIRED

YES NO

Review sources to prevent or reduce incidence.

NO

Action Level 2

MAY BE PRESENT STATEMENT REQUIRED

Determine level of allergen and assess against VITAL grid

Action Level 1

Is the allergen above

Persistent uncontrolled occurrence?

Action Level 1

Is the allergen above YES

YES

VITAL DECISION PROCESS

YES

NO CROSS CONTACT

STATEMENT REQUIRED 15


• Collects and assesses information about allergen risk in ingredients, equipment and control processes

• PC compatible only

• Summary page for customers

• PDF report

• Long term plan to move to web-based application

VITAL CALCULATOR (V2.1.18)

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Action Level 1 - precautionary cross contact statement is not required

Action Level 2 - precautionary cross contact statement is required

“May be Present:”


EXAMPLE VITAL REPORT

Exceeds Action level 1 Particulate form

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VITAL ADVANTAGE

Guides review and management of allergen risk

Consistent and systematic approach to: Assess allergens and cross contact allergens present

in ingredients. Assess manufacturing process for cross contact

allergens.

Demonstrates due diligence for supply chain

Reduce time/cost in responding to consumer complaints and product recall

Consistent risk assessment and labelling across industry

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VITAL AND CONSUMERS

• VITAL provides a consistent approach to assessing cross contact allergen risk

• VITAL encourages the elimination of cross contact allergens where possible within manufacturing or via material supplier

• Promotes consistency in allergen labelling

• Assist in making safe food choices

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Essential information for allergic consumers to manage dietary risk Need allergen labelling format that helps consumers by ensuring it is:

– simple plain language – unambiguous – easily identifiable – associated with or near the

ingredient list

LABELLING – A CONSUMER PERSPECTIVE

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RECOMMENDED LABELLING FORMAT

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INGREDIENTS

Water, vegetable oil, vinegar, cane sugar, tomato paste (5%), salt, parmesan cheese (2%), egg yolk, maize thickener (1412), almonds, red capsicum, soybean oil, garlic (1.0%), vegetable gum (415), spice, herbs, wheat cornflour, flavour (wheat maltodextrin, sesame oil), antioxidant (320)

Contains milk, egg, almonds, soy, wheat and sesame May be present: xxx, xxx, xxx

Tree nuts specifically identified

Allergenic ingredients & derivatives declared in bold each time they appear

Gluten source (grain source) qualified in ingredient list

Summary statement listing all allergenic ingredients in the product as per the table to clause 4 Statement should start with ‘Contains…’

Precautionary statement declared if appropriate. This statement must only be used in conjunction with the VITAL

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RECOMMENDED ALTERNATIVE FORMAT

• Recognise that limited space or packaging may limit ability to adopt all.

• Acceptable variations are:

– bolding and qualifying allergenic substances optional when summary statement is present

– if summary statement NOT present then allergenic substances should be bolded and qualified in ingredient list.

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• A free to use iPhone application that delivers trusted, authorised product data to consumers

• Wide collaboration with NGOs, universities, industry associations, retailers and manufacturers

• Provides consumers ease of use and readability, alert warnings, searchability extended information

• Supports all food and beverage products in the market, branded products & private label, local & imported

• Manufacturer direct information, irrespective of retail outlet, maintained and updated by manufacturer as new products released to market

MOBILE PHONE APPLICATION

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EXTENDED LABELLING – CONSUMER CHOICE

Consumer/Product Mobile phone Brand/Retailer

Key concept: Consumers access to trusted product information or related services via their mobile phone

They receive the answer from a trusted source

A consumer has a question about a product they are

buying.

They use their mobile phone to scan the barcode

on the label.

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CATEGORIES

• Once a product record has been found on GS1 Databank (the database that GS1 GoScan relies on for product data) the categories screen is displayed

• All categories for which the brand owner has provided data are enabled

• From this screen, the consumer can navigate to the section which contains the data of interest…

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Consumer profile ensure that Allergen Alert screen displays first when product is scanned

All Allergens declared as “Contains” will be shown at the

top of the screen

All Allergens declared as “May

contain” will be shown

underneath

Large easy to read font, which can be further expanded on screen and, can be read using audio assist program.

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ALLERGEN SCREENS


Extended labelling information providing detailed information about the type of allergens and clarifying terms.

Provides advice on foods to avoid, symptoms, variety of foods that contain the allergen, managing food in the home, etc.

Allergen information sourced from Anaphylaxis Australia, Coeliac Australia and FSANZ

EXTENDED INFORMATION

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CONSULTATION AND SUPPORT

Special thanks Georgina Christensen [email protected]

mailto:[email protected]



KIM LEIGHTON

DIRECTOR, POLICY AND REGULATION

AFRIS. AsianFoodRegulationInformationService.

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