Thresholds - VITAL Concept. Allergen analysis what should we consider when moving towards allergen thresholds? Pauline Titchener Product Manager

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1 Allergen analysis what should we consider when moving towards allergen thresholds? Pauline Titchener Product Manager Thresholds - VITAL Concept Utilises Action Levels concept Action Levels are determined using the Reference Dose and the Reference Amount/Serving Size. The reference dose is defined as the milligram protein level below which only the most sensitive individuals in the allergic population are likely to experience an adverse reaction. Source: 1

2 Implications of portion size for methods Allergen Ref. Dose 50g Cereals that contain gluten Egg Fish Peanut Soy Milk Nuts Mustard Sesame Lupin <0.6 <2 Portion Size Action Level 1 <4 <20 <2 <2 <1 <4 <80 100g 20 < g 5 <0.15 <1 <0.5 <2 <1 <10 <5 <1 <0.5 <1 <0.5 <0.5 <0.25 <2 <40 <1 <20 How much allergen could be in the product? Raw materials assessment what allergen risks are present in the raw materials/ how much allergen is present? Cross contact through the process how much allergen is present in the previous batch/how much is likely to remain? Processing dilution through water addition/ concentration through drying? Finished product testing to verify the above 2

3 Where would thresholds not be applicable? If the food allergen of concern is intentionally included an ingredient, additive or processing aid The food is targeted towards infant consumption or the food is marketed to persons intolerant or allergic to food allergen in question e.g. free-from GMP has not been optimised Documented allergen risk assessment indicates that the risk of allergen cross-contamination is remote Source: Campden BRI Guideline 71, 2013 Reporting units or Reference doses are in mg protein 3

4 Protein conversions Databases available for protein conversion e.g. USDA, McCance and Widdowson Comparison between methods Method ELISA LCMS:MS PCR Target Protein Peptides DNA Calibrators Standards from whole allergenic food Standards from protein fractions Labelled peptides Need an agreed reference point for all methods for each allergen 4

5 Key Factors to consider for testing What is the physical nature of food allergen? Sampling? Effect of processing on the allergen? Matrix effects? Physical nature of the food allergen Naturally grown food commodities, degree of variability in protein profile due to agronomic conditions and plant varieties Particulate or readily dispersible? How much is in product recipes e.g. seasoning mixes? Protein content of different types of allergen ingredients? 5

6 Impact of allergen format on detection Treenut Form Sensitivity () Walnut Hazelnut Cashew English 1 Black 1 Defatted 1 Oil Roasted 10 Meal 1 Shelled 5 Flour 2.5 Oil Roasted 20 Dry Roasted 2.5 Defatted 1 Raw 2.5 Flour 5 Oil Roasted 5 Dry Roasted 5 Defatted 2.5 Sampling Analytical error is associated with sampling, important to ensure that the sample to be tested reflects the batch and that distribution of allergen can be random or in hot spots If contamination is not homogenous, this presents challenges for sampling and analysis. 6

7 Effect of food processing As ELISA tests are based on antibody reaction with extracted protein, the protein in the sample must be close to it s natural state and readily extractable. Examples of instances where this may not be case include: Hydrolysed proteins Fermented products and cultures Processing aids Enzyme proteases Some concentrated food additives, flavouring and colourings Some oil based ingredients (oil, oil-based flavours) Also, consider the effects of food processing conditions on the allergen to be detected Summary Analytical methods available to cover majority of EU food allergens There are some areas that are a challenge Celery/Molluscs thresholds not available Portion size and sensitivity for some methods Reporting units and reference materials As factory processes and products vary it is necessary to carry out validation with the allergen method to be used 7

8 Thank you for your attention. Neogen Europe Ltd Tel: +44 (0) Fax: +44 (0)