FOOD ALLERGEN MANAGEMENT TOOLKIT

Canadian Spice Association AGMMay 6, 2016

Presented by

Tiina Henkusens Anthony Gene Andrew Sweet

Agenda

� Allergen Labelling & Allergen Management Resources

� Allergen Control Program

� Analytical Services

RESOURCES

Changing Regulatory Environment

• Canada’s food allergen labelling regulations came into force August 4, 2012

• 2007 Food Safety Action Plan enhanced surveillance initiative, targeted surveys were used by CFIA between 2010 – 2012 to evaluate various foods for specific hazards

• Increased oversight of imports, exports & domestic production with CFIA modernization & Safe Foods for Canadians Act/Regulations

International Food Allergens

Source: http://farrp.unl.edu/f0c3a875-ce07-404f-b05f-8a7983e57daa.pdf

• Increase in global trade

• Food allergen laws vary by region

• Manage food allergens according to the receiving country’s requirements

Health Canada – Allergen Labelling

� Health Canada's Amendments to the Food Allergen Labelling Regulations

� Health Canada's Position on Highly Refined Oils Derived from Food Allergen Sources

� Mustard: A Priority Food Allergen in Canada - A Systematic Review

Health Canada – Precautionary Allergen Statements

� Health Canada's policy for enhancing the protection of food-allergic consumers in Canada is based on two guiding principles:

◦ prevent the inadvertent consumption of undeclared allergens by sensitive consumers; and

◦ enable a variety of safe and nutritious food choices for the allergic consumer

� Precautionary labelling should only be used when, despite all reasonable measures, the inadvertent presence of allergens in food is unavoidable

� It must not be used when an allergen or allergen-containing ingredient is deliberately added to a food or when there is no real risk of an allergen being present in the food

� "may contain [X]”, where X is the name by which the allergen is commonly known

� http://www.hc-sc.gc.ca/fn-an/label-etiquet/allergen/precaution_label-etiquette-eng.php

CFIA – HACCP Generic Model for Spices

� In an effort to help reduce the risk associated with spices and assist manufacturers that wish to adopt a Hazard Analysis Critical Control Point (HACCP) approach, CFIA has developed the Food Safety Practices Guidance for Spice Manufacturersdocument

� Applies to Div 7 spices

http://www.inspection.gc.ca/food/safe-food-production-systems/haccp-generic-models-and-guidance-documents/guidance-spices/eng/1366340448103/1366340494598?chap=0#c1

Example,

Health Canada / CFIA - Gluten Free

� A gluten-free claim is any representation in labelling or advertising that states, suggests or implies that a food is gluten-free, as per B.24.018 of the Food and Drug Regulations (FDR)

� Foods containing gluten as a result of intentional addition may not be represented as being gluten-free. However, if a manufacturer using a cereal-derived ingredient includes additional processing steps which are demonstrated to be effective in removing gluten, the food may be represented as gluten-free.

� Any gluten that is present due to cross-contamination in a food labelled gluten-free should be as low as reasonably achievable and must not surpass 20 ppm of gluten, a level that is considered protective for the majority of people with Celiac disease

Health Canada / CFIA - Gluten Free

� In instances where the gluten is present due to cross-contamination at a level of less than 20 ppm in the food, the CFIA will follow up with the manufacturer or importer regarding the presence of gluten in the product. These manufacturers and importers should have good manufacturing/importing practices (GMP/GIP) in place to achieve the lowest levels of gluten possible to avoid cross-contamination. However, based on Health Canada's position, enforcement action on products containing less than 20 ppm gluten as a result of cross-contamination will not include a recall of the product, nor a request to remove the gluten-free claim

� In all instances, regardless of source, if more than 20 ppm of gluten is present in a food labelled as gluten-free, the product may be in violation of the FDR Section B.24.018 and/or Section 5.1 of the Food and Drugs Act (FDA) and, on the basis of a health risk assessment provided by Health Canada, subject to appropriate enforcement action by the CFIA, which may include the possibility of recall

� http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/allergens-and-gluten/eng/1388152325341/1388152326591?chap=2

� http://www.hc-sc.gc.ca/fn-an/securit/allerg/cel-coe/avoine-gluten-oats-eng.php

Allergen-Free Claims

� General claims stating only "Allergen Free" or "No Allergens" are considered to be too broad in nature and are therefore not acceptable. The list of potential food allergen sources is not restricted to the list of priority food allergens identified by Health Canada.

� There are over 200 food proteins that can cause adverse reactions to some segments of the population. Therefore, it is likely to create an erroneous impression to state that a product is free of allergens

� http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/allergens-and-gluten/eng/1388152325341/1388152326591?chap=0

CFIA Targeted Surveys – Ground Spices

� As part of the 2007 Food Safety Action Plan enhanced surveillance initiative, targeted surveys were used by CFIA to evaluate various foods for specific hazards

� In 2010-11, a total of 268 ground spices were analysed for the presence of gluten

� Gluten is not permitted in single pre-packaged ground spices. It is therefore expected that single ground spices do not contain gluten; the unexpected presence of gluten may pose a health risk for sensitive individuals

� http://www.inspection.gc.ca/about-the-cfia/newsroom/news-releases/2012-08-15/eng/1344951042395/1344951257435

CFIA Targeted Surveys – Ground Spices

� Of the 268 samples, 63 samples (24%) contained detectable levels of gluten ranging from 5 ppm to 20,000 ppm.

� A number of factors are considered when determining if a food poses a health risk. The amount of the hazard, in this case gluten, that a person would ingest during a typical meal is a primary consideration. For single ground spices a serving size is relatively small at approximately 0.5 g.

� It was determined, in consultation with Health Canada, that 62 (97%) of the spices with detectable levels of gluten did not pose a risk to sensitive individuals. One sample of mace was determined to be in violation of the FDA and FDR. This product was recalled.

CFIA Targeted Surveys – Flavour Packets

� 2010 – 2011 allergen survey targeted a variety of flavour packets including: bake mixes, dessert mixes, sauce mixes, powdered drink mixes, seasonings, spices mixes and soup bases

� In 2014-2015, the CFIA conducted a follow-up survey. Any findings of undeclared allergens from the survey may be considered to be in violation of Section 5(1) of the Food and Drugs Act if allergens are added and not declared.

http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/list-of-ingredients-and-allergens/industry-notice-2013-07-08/eng/1373289087016/1426168102706

2010-2011 Survey Results for Gluten

Additional Resources

� ASTA

� Food Allergy Research and Resource Program (FARRP)

◦ University of Nebraska - Profs. Steve Taylor, Joseph Baumert, Melanie Downs, Richard Goodman and Philip Johnson serve as faculty members in the Department

◦ Analytical services, resources, research, workshops

◦ http://farrp.unl.edu/

� Food Allergy Canada

◦ http://foodallergycanada.ca/

ALLERGEN CONTROL PROGRAM

Allergen Control Program

� A requirement for any GFSI Programs

� Points for Consideration:

� Ingredient Cycle throughout the supply chain

�Product Cycle within the process

�Programs for claims, such as, Gluten free status

� Process Review for claims:

�How are Raw Materials verified

� Implementation of a risked base testing program or assessment steps on raw materials

�Risk assessment for cross contamination

�Validation data for the process and the product

Auditing Process

� Validation data for the process available for review

� Employee knowledge:

�At the plant level

�Technical team

� Tools utilized to communicate allergens across all levels

� Ingredient storage

Allergen Communication� Establish clear and accurate company policy on allergen labelling

� Develop communication strategies with service team:

�How to answer questions on food allergies efficiently

�Provide regularly updated information

� Keep communication simple and clear:

�Written, labelling, consumer services, Websites, etc.

� Refer consumers to organizations for people with food allergies

ANALYICAL SERVICES

Allergens Overview

May 3, 2016 Presented by Andrew Sweet

Agenda

● Maxxam – Who we Are?

● Allergens

● Common Kits in use

● How does it work?

● Sensitivity

● Common issues

● Any changes coming?

A Canadian Market Leader

A Maxxam snapshot

24May 3, 2016

Delivering a full suite of analytical services

and solutions

…through common processes across a national laboratory network

25May 3, 2016

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y • Oil and gas analysis

• Fuel testing

• Field sampling management

• Source & ambient testing

• Mobile laboratory

• Tailings characterization

• Pilot plant analysis

• Laboratory outsourcing

• Core analysis

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• Contaminated sites analysis

• Environmental forensics

• Emergency Response Services

• Analytical services for EIA and regulatory monitoring

• Ecotoxicology

• Acid Rock Drainage

• Ultra trace contaminant analysis (Air/HRMS)

• Radioactivity analysis

Foo

d • Microbiology

• Rapid methods

• Conventional methods

• Shelf life testing

• Food-borne illness investigations

• Food chemistry

• Nutritional labelling

• Residue testing

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• Forensic DNA testing

• Animal DNA-based parentage verification

• Paternity and immigration DNA testing

• Equine doping control

• Chemical Product testing

Our Canadian network

Over 40 laboratories and service centres

26May 3, 2016

Allergens

Allergens – Common Kits in Use

28May 3, 2016

Market leader in Allergen diagnostic kits – Peanut, R5 Gluten, Milk, Soy, Almond,

Egg, other. Has received some recognition with Health Canada and CFIA. Have

products applicable for in-plant detection and Laboratory Detection (lower

sensitivity, greater specificity)

Growing reputation for Peanut and Gluten testing. Have Health Canada approval

for Hazelnut.

While less recognized from a regulatory standpoint they are growing in popularity.

Kits are more user friendly and cater to the in-plant testing market.

How do Allergen kits work?

• Microwell plates – coated with capture antibody

• colour intensity of samples is read by a spectrometer (microwell reader) at test specific wavelengths.

Allergens - Sensitivity

30May 3, 2016

NOTE – Not all kits report the same units!!!

4 ug/g of Peanut1 ug/g of Peanut Protein

***Some kits report as ug/g of Peanut Protein and others as ug/g of Peanut. A peanut contains 25.8% of protien.

Common Issues with Testing

● How should the results be reported?

● Protein vs. food product

● Spices are a difficult commodity to test

● Treatment of food can alter the antigen

● Re-naturating of protein is most common method to prevent this

● Interference from complex compounds and proteins

● +ve and –ve bias

31May 3, 2016

Allergens – Any changes Coming?

32May 3, 2016

In development:

• Fish and Seafood

• More effective Allergen Determination in Spices/Seasonings

Interesting Case Study:

Final Thoughts…

33May 3, 2016

Food Recalls by Type - CFIA

Final Thoughts…

34May 3, 2016

Food Recalls by Allergen - CFIA

Spices & condiments segment - ~17% and ~16% of all recalls in 2014 and 2013 resp.

@MaxxamLab

Connect with us!

Key Takeaways…

� Food allergen recalls have increased

� Know the risks related to your product, facility & supply chain

� Understand the food allergen regulations & policies

� A gluten-free claim provides a competitive advantage and may require a targeted approach for claim validation

� Spices are complex. Be well informed of the science including available analytical methods

Questions?

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