Food Allergens Case Reports Dr Harris Steinman
Operational errors 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
Testing / Validation Assays / PCR! Swab! ELISA! PCR! Other..
Assays! Limitations of tests! Complex process foods: Multiple food allergens! Thresholds
Case report 1 Product tested: xxxx Mayo low fat (Egg free) Tested for: Egg (ELISA) Claims: Egg free claim made Results: >25 ppm egg protein Details: Use egg in other formulations
Case report 2 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 Product tested: xxxx Maize meal Tested for: Gluten (ELISA) Claims: No claims made 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 3 Product tested: xxxx Rice Tested for: Gluten (ELISA) Claims: None Wheat (PCR) Results: 8.24 ppm gluten Wheat negative? Details: Expected to be inherently gluten free Will contamination be controllable?
Case report 4 Product tested: xxxx Carob Powder Tested for: Gluten (ELISA) Claims: GLUTEN FREE CLAIM MADE Results: >20 ppm gluten
Case report 14! xxx Rice Milk
Case report 5 Product tested: Dairy-free creamer Rice milks Tested for: Milk (ELISA) Claims: Dairy free Results: >25 ppm milk
Case report 6 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 7 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 8 Product tested: xxxx Chicken polony Tested for: Soy (ELISA) Claims: SOY FREE CLAIM MADE Results: After BLENDING: After EMULSIFYING: After FILLING: < 2.5 ppm soy 10.9 ppm soy protein >25.0 ppm Details: Soy used in other formulations Soy-free claim still made!
Case report 9 Product tested: xxxx Macadamia oils Tested for: Macadamia nut (PCR) Results: Product tested Crude macadamia oil Refined macadamia oil Highly refined macadamia oil Macadamia-specific PCR Positive Positive Negative! Details: During refining process (refining, bleaching, deodorising) protein (allergens) removed?
Case report 10 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 12 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 31 Product tested: xxxx Gluten-free bread Tested for: Gliadin (ELISA) Claims: GLUTEN FREE CLAIM MADE Results: >80 ppm gluten
Case report 26 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 24 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 28 Product tested: xxxx Crackers Flavour 1 and 2 Tested for: Gluten Claims: Gluten free Results: Flavour 1 Flavour 2 FACTS >5 ppm gluten 35.30 ppm gluten Euro lab 1 Negative Negative Euro lab 2-50.0 ppm gluten Details: Batch variation?
Case report 32a
Case report 32b 30.00 Egg Content: Mayo Batch 4037 25.00 20.00 ppm 15.00 10.00 Ave. ppm total egg Ave. ppm egg protein 5.00 0.00 CFP CFP CFP CFP CFP CFP CFP CFP CFP CFP CFP CFP CFP CFP CFP CFP CFP 0723 0802 0830 0859 0957 1000 10051014 1137 1154 1214 1238 13031314 1420 17192024 Sample time
CCS Proximal allergens Beer! Beer barley (lipid transfer protein, gluten), hops, sorghum Testing (hydrolysed gluten) 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.
Case report 27 139 Processed meat samples 25% Undeclared Soy 32% Undeclared gluten Soy > 1,000 ppm
Fish Adulteration " 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%) 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.
Fish Adulteration " 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.
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
VITAL 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
Questions VITAL can answer Standardised risk based methodology Impact of cross contamination Reduce promiscuous precautionary labelling Appropriate precautionary labelling
Ingredient vs Cross-contact Ingredient Wheat Starch may contain soy ELISA: 0 5ppm Cross Contact Fish paste 100 ppm ELISA: 100ppm
Scientific Data Underpining VITAL 2.0 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
Voluntary Incidental Trace Allergen Labeling Allergen name Almonds & their products Brazil nuts & their products Cashews & their products Hazelnuts (filberts) & their products Macadamia nuts & their products Pecans & their products Pine nuts (pignolias) & their products Pistachio nuts & their products Walnuts & their products Wheat or its derivadves or hybridised strains Rye or its derivadves or hybridised strains Barley or its derivadves or hybridised strains (short.tle) Reference Dose (mg of protein) Almond 0.1 Brazil nut 0.1 Cashew 0.1 Hazelnuts 0.1 Macadamia nut 0.1 Pecan 0.1 Pine nut 0.1 Pistachio nut 0.1 Walnut 0.1 Wheat 1 Rye 1 Barley 1 Allergen name Oats or its derivadves or hybridised strains Spelt or its derivadves or hybridised strains (short.tle) Reference Dose (mg of protein) Oats 1 Spelt 1 Egg & egg products Egg 0.03 Crustacea & their products Finfish and finfish products (excluding molluscs) Crustacea 10 Fish 0.1 Milk & milk products Milk 0.1 Peanut & peanut products Sesame seeds & sesame seed products Soybeans & soybean products Peanut 0.2 Sesame seed 0.2 Soy 1 Lupin & lupin products Lupin 4 Mustard & mustard products Mustard 0.05
VITAL 2 LOAELS* 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
Takes into account cross contact risks from ingredients and processing Differs for particulate and readily dispersible forms Decision tree for identifying appropriate advisory labelling 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 6. Carry over / Hang-up 7. Mass Carry over 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
Dispersible Directs to VITAL calculator
Directs to Action level 1 or Action Level 2
Decision tree for identifying appropriate advisory labelling
Takes into account cross contact risks from ingredients and processing Differs for particulate and readily dispersible forms Decision tree for identifying appropriate advisory labelling Particulate = distinct particles (e.g. nut) contamination likely not homogenous Readily dispersible powder of liquid contamination likely homogenous Directs to VITAL calculator Directs to Action level 1 or Action Level 2
Carine Davies Registered Dietician Comaine van Zyl Food Scientist Shafeeqah Allie Administration Karen Horsburgh Registered Dietician Harris Steinman Debora v.d. Merwe Food Scientist (Ph.D.) Donna Cawthorn Food Scientist (Ph.D.) Jana du Plessis MSC Genetics www.factssa.com info@factssa.com