Food Allergens

Dr Harris Steinman

Case Reports

Allergen-related product recalls are mainly a result of some simple operational errors: !  Failure in the review and approval of product labels

!  Failure to load and/or change to the correct product packaging

!  Failure to ensure separate tools are used to handle specific allergenic ingredients

!  Failure to notice the presence of allergens on a supplier certificate of analysis

Allergen management as a part of A safe global food supply chain. SGS. June 2014

Operational errors

!  Raw ingredients

!  Manufacturing process •  Rework •  Cross-contamination

!  Packaging and labelling

!  Regulatory

!  Deliberate

Operational errors

Testing / Validation

Assays / PCR

!  Swab

!  ELISA

!  PCR

!  Other . .

Assays

!  Limitations of tests

!  Complex process foods: Multiple food allergens

!  Thresholds

Product tested: xxxx Mayo low fat (Egg free)

Tested for: Egg (ELISA)

Claims: Egg free claim made

Details: Use egg in other formulations

Results: >25 ppm egg protein

Case report 1

Product tested: xxxx Maize Flour

Tested for: Gluten (ELISA)

Soy (ELISA)

Claims: No claims made

Results: > 25 ppm soy protein > 80 ppm gluten

Details: They use gluten & soy in their facility

Case report 2

Details: Expected to be gluten free

1 maize meal a 15.30 ppm b 18.5 ppm

2 maize meal a < 5.0 ppm b < 5.0 ppm

3 maize meal a 43.4 ppm b 36.4 ppm

4 maize meal a 62.0 ppm b 50.0 ppm

5 maize meal a 8.3 ppm b 14.7 ppm

6 maize flour a 80.0 ppm b 73.0 ppm

7 maize rice a < 5.0 ppm b < 5.0 ppm

8 maize samp a < 5.0 ppm b < 5.0 ppm

Case report 2

Product tested: xxxx Maize meal

Tested for: Gluten (ELISA)

Claims: No claims made

Product tested: xxxx Rice

Tested for: Gluten (ELISA)

Wheat (PCR)

Claims: None

Results: 8.24 ppm gluten Wheat – negative?

Details: Expected to be inherently gluten free

Will contamination be controllable?

Case report 3

Product tested: xxxx Carob Powder

Tested for: Gluten (ELISA)

Claims: GLUTEN FREE CLAIM MADE

Results: >20 ppm gluten

Case report 4

! xxx Rice Milk

Case report 14

Product tested: Dairy-free creamer

Rice milks

Tested for: Milk (ELISA)

Claims: Dairy free Results: >25 ppm milk

Case report 5

Product tested: xxxx Yoghurt culture and probiotic

Tested for: Milk

Method of Testing: Milk ELISA

Claims: Unsure if milk-free claim made, but milk not indicated in ingredient list

Results: >1200 ppm milk protein

Details: Milk proteins may be incorporated from culture medium.

Case report 6

Product tested: xxxx Frozen chicken

Tested for: Milk

Method of Testing: Milk ELISA

Claims:

Results: 13 ppm milk protein

Details: Likely to be incorporated in brine,

but not labelled

Case report 7

Product tested: xxxx Chicken polony

Tested for: Soy (ELISA)

Claims: SOY FREE CLAIM MADE Results:

After BLENDING: < 2.5 ppm soy After EMULSIFYING: 10.9 ppm soy protein After FILLING: >25.0 ppm

Details: Soy used in other formulations

Soy-free claim still made!

Case report 8

Product tested: xxxx Macadamia oils

Tested for: Macadamia nut (PCR)

Results:

! Details: During refining process (refining, bleaching, deodorising) – protein (allergens) removed ?

Product tested Macadamia-specific PCR

Crude macadamia oil Positive Refined macadamia oil Positive

Highly refined macadamia oil Negative

Case report 9

Product tested: xxxx Spelt cakes

Tested for: Wheat

Method of Testing: Wheat – specific PCR

Claims: WHEAT FREE CLAIM MADE

Results: POSITIVE

Details: Spelt is wheat!

Case report 10

Tested: xxxx Final wash water after ice-cream run (biscuit)

Tested for: Wheat

Method of Testing: Wheat – specific PCR

Claims:

Results: POSITIVE

Details: Cleaning ineffective in removing wheat

Case report 12

Product tested: xxxx Gluten-free bread

Tested for: Gliadin (ELISA)

Claims: GLUTEN FREE CLAIM MADE

Results: >80 ppm gluten

Case report 31

Product tested: xxxx Fruit Juice Concentrate

Tested for: Milk (ELISA)

Claims: None, but not expected

Results: >25 ppm milk protein

Details: Use milk in facility in other formulations

Case report 26

Product tested: xxxx Pumpkin seed Rye Bread

Tested for: Wheat

Method of Testing: Wheat-specific PCR

Claims: Wheat free

Results: Positive for wheat

Details: Wheat-free claim

Case report 24

Case report 28

Product tested: xxxx Crackers Flavour 1 and 2 Tested for: Gluten

Claims: Gluten free

Results:

Details: Batch variation?

Flavour 1

Flavour 2

FACTS >5 ppm gluten 35.30 ppm gluten

Flavour 1

Flavour 2

FACTS >5 ppm gluten 35.30 ppm gluten

Euro lab 1 Negative Negative

Euro lab 2 - 50.0 ppm gluten

Case report 32a

0.00

5.00

10.00

15.00

20.00

25.00

30.00

CFP 0723

CFP 0802

CFP 0830

CFP 0859

CFP 0957

CFP 1000

CFP 1005

CFP 1014

CFP 1137

CFP 1154

CFP 1214

CFP 1238

CFP 1303

CFP 1314

CFP 1420

CFP 1719

CFP 2024

ppm

Sample time

Egg Content: Mayo Batch 4037

Ave. ppm total egg

Ave. ppm egg protein

Case report 32b

!  Beer – barley (lipid transfer protein, gluten), hops, sorghum

•  Testing (hydrolysed gluten)

CCS – Proximal allergens – Beer

Song Z, Chen W, Huang X, Zhou X, Luo J, Wang H, Darsow U, Becker T, Qian F, Hao F, Ring J. Sensitization to beer ingredients in Chinese individuals with beer allergy: a clinical study of 20 cases. Int Arch Allergy Immunol 2013 Dec 14;163(2):135-141

Oats Research

Cawthorn DM, Steinman HA, Witthuhn C. Wheat and gluten in South African food products. Food and Agricultural Immunology 2010;21(2):91-102.

139 Processed meat samples

25% Undeclared Soy

32% Undeclared gluten

Soy > 1,000 ppm

Case report 27

"   Distributor/wholesale samples: 10.5% mislabeled

"   Retail samples: 29.6% mislabeled

"   Overall: 19% mislabeled!

"   Highest fish species misrepresentation: KZN - 56% fish samples mislabelled GP (29%), WC (25%), and EC (15%)

Fish Adulteration

Cawthorn D, Steinman HA, Witthuhn C. Establishment of a mitochondrial DNA sequence database for the identification of fish species commercially available in South Africa. Mol Ecol Resour. 2011 Nov;11(6):979-91.

" Swordfish and white-steenbras were actually butterfish

" Kingklip ~ closely related “ling” from Aus/NZ – 25% substituted

1.  Cawthorn D, Steinman HA, Witthuhn C. Establishment of a genetic database for the identification of South African fish species: a step towards preventing commercial fraud and promoting sustainable fisheries. Poster. Hungary.

2.  Cawthorn D, Steinman HA, Witthuhn C. Comparative study of different methods for the extraction of DNA from fish species commercially available in South Africa. Food Control 2011;22(2):143-346.

3.  Cawthorn D, Steinman HA, Witthuhn C. Establishment of a mitochondrial DNA sequence database for the identification of fish species commercially available in South Africa. Mol Ecol Resour. 2011 Nov;11(6):979-91.

4.  Cawthorn D, Steinman HA, Witthuhn C. DNA barcoding of the Cytochrome C Oxidase I (COI) gene reveals a high incidence of fish species misdescription and substitution on the South African market. Food Research International. Cawthorn D, Steinman HA, Witthuhn C. Evaluation of the 16S and 12S RRNA genes as universal markers for the identification of commercial fish species in South Africa. Gene. 2011 Sep 21.

Fish Adulteration

VITAL  2  Precau.onary  Labelling  &  Risk  Assessment  Tool

!  VITAL (Voluntary Incidental Trace Allergen Labelling) (Version 2.0)

!  Food Standards Aus/New Zealand (FSANZ) Allergen bureau

WHAT IS VITAL?

!  A set of allergen risk assessment tools for determining:

•  Risks of allergen cross contamination

•  When and if precautionary labelling should be used

COMPONENTS OF VITAL?

!  VITAL Decision Tree

!  Interactive VITAL calculator

VITAL

•  Standardised risk based methodology

•  Impact of cross contamination

•  Reduce promiscuous precautionary labelling

•  Appropriate precautionary labelling

Questions VITAL can answer

Ingredient Wheat Starch

“may contain soy”

ELISA: 0 – 5ppm

Cross Contact Fish paste 100 ppm

ELISA: 100ppm

Ingredient vs Cross-contact

Threshold Amounts •  New clinical oral challenge threshold data

•  Developed new threshold input values

•  Using 3 statistical models

•  Safety margin build in

•  95 – 99% no observed reaction

•  5 – 1% most sensitive mild reactions – no pharmacological intervention

Scientific Data Underpining VITAL 2.0

Voluntary  Incidental  Trace  Allergen  Labeling  

Allergen  name   (short  .tle)   Reference  Dose  (mg  of  protein)  

Almonds  &  their  products   Almond   0.1  

Brazil  nuts  &  their  products   Brazil  nut   0.1  

Cashews  &  their  products   Cashew   0.1  

Hazelnuts  (filberts)  &  their  products   Hazelnuts   0.1  

Macadamia  nuts  &  their  products   Macadamia  nut   0.1  

Pecans  &  their  products   Pecan   0.1  

Pine  nuts  (pignolias)    &  their  products   Pine  nut   0.1  

Pistachio  nuts    &  their  products   Pistachio  nut   0.1  

Walnuts    &  their  products   Walnut   0.1  

Wheat  or  its  derivaDves  or  

hybridised  strains  Wheat   1  

Rye  or  its  derivaDves  or  hybridised  strains   Rye   1  

Barley  or  its  derivaDves  or  

hybridised  strains  Barley   1  

Allergen  name   (short  .tle)   Reference  Dose  (mg  of  protein)  

Oats  or  its  derivaDves  or  hybridised  strains   Oats   1  

Spelt  or  its  derivaDves  or  hybridised  strains   Spelt   1  

Egg  &  egg  products   Egg   0.03  

Crustacea  &  their  products   Crustacea   10  

Finfish  and  finfish  products  (excluding  

molluscs)  Fish   0.1  

Milk  &  milk  products   Milk   0.1  

Peanut  &  peanut  products   Peanut   0.2  

Sesame  seeds  &  sesame  seed  products   Sesame  seed   0.2  

Soybeans  &  soybean  products   Soy   1  

Lupin  &  lupin  products   Lupin   4  

Mustard  &  mustard  products   Mustard   0.05  

LOAELs for food allergens: *

Allergen LOAEL (mg protein) Egg 0.03

Peanut 0.2 Milk 0.1

Tree Nuts 0.1 Soy 1 Fish 0.1

*Lowest-observed-adverse-effect level

VITAL 2 LOAELS*

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Takes into account cross

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processing

Differs for particulate and readily dispersible forms

Directs to VITAL calculator

Directs to Action level 1 or Action Level 2

1. Raw materials

2. Test results

3. Hydration & Dehydration

4. Serving Size / Reference Amount

5. Process cross-contamination

7. Mass Carry over

6. Carry over / Hang-up

8. Particulate v.s. Readily Dispersable

9. % Protein cross-content material

10. Batch size

Takes into account cross contact risks

from ingredients and

processing

Differs for particulate and

readily dispersible forms

Directs to VITAL calculator

Dispersible

Directs to Action level 1 or Action

Level 2

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ntify

ing

a

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ad

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Takes into account cross

contact risks from ingredients and

processing

Differs for particulate and readily dispersible forms

Directs to VITAL calculator

Directs to Action level 1 or Action Level 2

Particulate = distinct particles (e.g. nut) – contamination likely not homogenous

Readily dispersible – powder of liquid – contamination likely homogenous

Harris Steinman

Carine Davies Registered Dietician

Karen Horsburgh Registered Dietician

Donna Cawthorn Food Scientist (Ph.D.)

Shafeeqah Allie Administration

Debora v.d. Merwe Food Scientist (Ph.D.)

www.factssa.com  info@factssa.com  

Comaine van Zyl Food Scientist

Jana du Plessis

MSC Genetics