1. Customer Focused, Science Driven, Results Led The Testing Implications for Making Free-from Food Myth versus Reality Sonia J. Miguel

2. Free-from legal requirements Testing: how much, how and where? How do things change if you scale up? Economic implications Free-from versus action levels Overview

3. Gluten-free food products are the only free-from products currently covered by legislation There is no legislation to cover the claims dairy- free, milk-free, egg-free, nut-free or allergen-free But all should comply with: Food Safety Act 1990 EC/852/2004 Directive Food Information Regulation 2011 Free-from Legal Requirements

4. 1983 Codex Standard products labelled gluten- free if <200 ppm gluten in finished product Revised standard in 2007 – Reduced the limit to <20 ppm gluten (gluten-free) – New claim of very low gluten for products <100 ppm gluten New EC Regulation No. 41/2009 came into force in January 2012 History of Gluten-free Labelling

5. Gluten-free Labelling EC Regulation No. 41/2009 Covers gluten-free <20 ppm as sold, not consumed Very low gluten <100 ppm (food containing cereal ingredients that have been processed to remove gluten) Covers all foods pre-packed and loose Food containing cereal derived ingredients that are <20 ppm could be labelled gluten-free but cereals would need to be declared as ingredients – potentially confusing to consumers!

6. Business has done everything reasonable practical to manage allergens There is a system Can prove that it has operated diligently The system must be shown to work Concept of Due Diligence

7. The size of the company doesnt matter, the legal requirements are the same: Food Safety Act 1990 EC/852/2004 Directive Food Information Regulation 2011 Gluten-free Labelling. EC Regulation No. 41/2009 Same rules in all countries in the EU Does Size Matter?

8. Effective Allergen Control Supply Chain Assessment Sampling & Analysis HACCP Principles Training Prerequisites (GMP ) Informed Labelling Validation Verification Monitoring

9. Results only as representative as samples submitted Sampling plan linked to risk analysis to maximise probability of detecting contamination (if present) Plan must consider following factors: How Much Sampling and How Often? Physicochemical nature of the allergenAssociated protein levelHeterogeneous or homogeneous contaminationConcentration in recipeLevel of processing allergenic material undergone

10. Protein based techniques – Separation technique Liquid chromatography-mass spectrometry (LC-MS) – Immunochemistry assays Enzyme linked immunosorbent assay (ELISA) Rapid lateral flow devices (RLFD) DNA based technique – Polymerase chain reaction (PCR and PCR-RT) Analytical Techniques

11. Based on antibody/antigen interaction Antibodies are raised mainly against specific allergenic proteins Clinically relevant (proven to cause reaction) Quantitative within a standard range Very specific and sensitive method (low mg/kg) ELISA

12. Internal validation (spike recovery/inhibition studies) Matrix Effects

13. Validation is vital Wide range of devices on the market Rapid Lateral Flow Devices (RLFDs)

14. Antibodies on the market: R5, Skerritt & Hill, polyclonal, G12 Each antibody is specific to a different epitope = different sensitivity Different extraction protocols = different recoveries Codex endorsed the R5 antibody but the regulation does not Choosing the Best ELISA Test for the Detection of Gluten?

15. Choosing the Best ELISA Test for the Detection of Milk? Total milk Milk proteins 36% Casein 80% Whey protein 20% Beta- lactoglobulin 50% Other whey proteins Lactose sugarFat Allergenic contamination source AntibodiesCalibratorConversion to total milk protein Skimmed milk powder (SMP) CaseinTotal milk proteins Result Beta- lactoglobulin Total milk proteins Result Milk proteinsTotal milk proteins Result Milk proteinsSMPResult * 0.36 CaseinatesCasein Result * 1.25 Whey proteinsBeta- lactoglobulin Result * 10

16. UKAS accredited Verify ELISA kit manufacturers claims Validate all new matrices for each ELISA kit Test for inhibitors in PCR reactions Inter-lab ring-trials (FAPAS) Who Can Do It for You?

17. From Your Kitchen to the Factory Review your risk assessment – External support Training of your staff – Awareness Supplier chain Retailer – Code of practice, usually different for each retailer – British Retail Consortium (BRC)

18. Updates in current version Documented risk assessment to identify routes of contamination Documented policies and procedures to avoid cross contamination Policy prescriptive BRC v6 Requirements

19. What Are The Cost Implications? Testing – Risk assessment must guide you to how much and what kind of testing is most appropriate Risk assessment Training for awareness at different levels Consumer complaints

20. Recommended allergen action levels VITAL 2.0 Free-from vs Action Levels Allergen nameTotal protein from food (mg) Peanut0.2 Milk0.1 Egg0.03 Hazelnut0.1 Soya1 Wheat1 Cashew2 Mustard0.05 Lupin4 Sesame seeds0.2 Shrimps10 FIS Europe Jan 2012 Dr. Sylvia Pfaff

21. Free-from vs Action Levels

22. Thank you for your attention Any questions? Sonia.j.miguel@rssl.com 0118 9184000 Sonia.j.miguel@rssl.com